Endoscopic Staples Including Anchorage Mechanisms

ABSTRACT

A device for closing a tissue opening includes a body extending from a first end to a second end and a first anchoring element connected to the first end of the body and a second anchoring element connected to the second end of the body. At least one of the first anchoring element and the second anchoring element is movable between an insertion configuration, in which the at least one of the first and second anchoring elements is insertable through a target tissue such that the body extends across a tissue opening to be treated, and an anchoring configuration, in which the first and second anchoring elements engage target tissue on a first side and a second side, respectively, of the tissue opening.

PRIORITY CLAIM

The present disclosure claims priority to U.S. Provisional PatentApplication Ser. No. 62/048,437 filed Sep. 10, 2014; the disclosure ofwhich is incorporated herewith by reference.

BACKGROUND

Physicians have been increasingly willing to perform more aggressiveinterventional and therapeutic endoscopic procedures including, forexample, the removal of larger lesions (e.g., cancerous masses),tunneling under the mucosal layer of the gastrointestinal (GI) tract totreat tissue below the mucosa, full thickness removal of tissue, thetreatment of issues on other organs by penetrating and passing of the GItract, and the endoscopic treatment/repair of post-surgical issues(e.g., post-surgical leaks, breakdown of surgical staple lines,anastomic leaks). These procedures my increase the risk of perforatingthe wall of the GI tract, or may require closure of the GI tract wall aspart of the procedure. Endoscopic stapling devices may be used to treatsuch tissue openings/perforations. Current stapling devices, however,may prove difficult to use and/or may be insufficient to close certainperforations or to treat certain conditions.

SUMMARY

The present disclosure is directed to a device for closing a tissueopening, comprising a body extending from a first end to a second endalong with a first anchoring element connected to the first end of thebody and a second anchoring element connected to the second end of thebody, at least one of the first anchoring element and the secondanchoring element movable between an insertion configuration, in whichthe at least one of the first and second anchoring elements isinsertable through a target tissue such that the body extends across atissue opening to be treated, and an anchoring configuration, in whichthe first and second anchoring elements engage target tissue on a firstside and a second side, respectively, of the tissue opening.

In an embodiment, the body may further include a first leg extendinglaterally from the first end of the body with the first anchoringelement extending along a portion thereof and a second leg extendinglaterally from the second end with the second anchoring elementextending along a portion thereof.

In an embodiment, the first leg and the second leg may extendsubstantially perpendicular to the body and parallel to one another.

In an embodiment, the body extends along a curve.

In an embodiment, the body is biased to extend along the curve.

In an embodiment, at least one of the first and second anchoringelements may include a first portion and a second portion pivotallycoupled to one another at a pivot point, the first and second portionspivoting between the anchoring configuration, in which the pivot pointextends away from a corresponding one of the first and second ends, andthe insertion configuration, in which the pivot point moved toward thefirst and second legs.

In an embodiment, each of the first and second anchoring elements may beformed from a cut portion of the body that is cut away from an exteriorsurface thereof, the cut portion extending from a first end connected tothe body to a second free end, the second end of the cut portion biasedaway from a remaining portion of the body in the anchoringconfiguration, and movable toward the remaining portion of the body inthe insertion configuration.

In an embodiment, at least one of the first and second anchoringelements may be an inflatable bulb, the inflatable bulb being inflatedin the anchoring configuration and deflated in the insertionconfiguration.

In an embodiment, at least one of the first and second anchoringelements may be a cap couplable to a corresponding one of the first andsecond ends of the body.

The present disclosure is also directed to a device for closing a tissueopening, comprising an outer member biased to extend along a curve froma distal end to a proximal end and including a first lumen extendingtherethrough in combination with an inner member slidably receivedwithin the first lumen of the outer member and movable relative theretobetween an insertion configuration and an anchoring configuration, theinner member being biased to extend along a curve from a distal end to aproximal end, wherein, in the insertion configuration, the distal end ofthe inner member is received within a proximal portion of the firstlumen, and, in the anchoring configuration, the inner member is moveddistally relative to the outer member such that the distal end thereofextends distally past the distal end of the outer member and a firstanchoring element connected to the proximal end of the inner member suchthat, in the anchoring configuration, the first anchoring elementextends proximally from the proximal end of the outer member to anchorthe device in a target tissue.

In an embodiment, the inner member may include a second lumen extendingtherethrough.

In an embodiment, the device may further comprise a second anchoringelement connected to the distal end of the outer member.

In an embodiment, each of the first and second anchoring elements may bean inflatable bulb, the inflatable bulb deflated in the insertionconfiguration and inflated in the anchoring configuration, the firstlumen of the outer member including an inflating fluid therein so that,when the inner member is moved distally relative to the outer memberfrom the insertion configuration to the anchoring configuration, theinflating fluid is displaced, filling the inflatable bulb of the firstand second anchoring elements.

In an embodiment, the inner member may be a wire including a secondanchoring element at the distal end thereof, each of the first andsecond anchoring elements being formed via a portion of the wire biasedto bend laterally away from the proximal and distal ends thereof.

In an embodiment, in the insertion configuration, the second anchoringelement may be housed within the first lumen and, in the anchoringconfiguration, extends distally of the distal end of the outer member toanchor the device in a target tissue.

The present disclosure also relates to a method for treating a tissue,comprising inserting a staple device into a target tissue via a deliverycatheter passed through a working channel of an endoscope, the stapledevice including an outer member biased to extend along a curve from adistal end to a proximal end and an inner member slidably receivedwithin a first lumen of the outer member and biased to extend along acurve from a distal end to a proximal end, the outer and inner membersconstrained in a straight position via an interior surface of the firstlumen in an insertion configuration, the distal end of the inner memberreceived within a proximal portion of the first lumen in the insertionconfiguration, moving the outer and inner members distally relative tothe delivery catheter so that the outer member is inserted into a targettissue until the distal end of the outer member extends proximally of aproximal surface of the target tissue, the outer member reverting to abiased curved configuration as the outer member is moved distally out ofthe delivery device, and moving the device from the insertionconfiguration to the anchoring configuration by moving the inner memberdistally relative to the outer member until a first anchoring element atthe proximal end of the inner member is moved distally out of thedelivery catheter.

BRIEF DESCRIPTION

FIG. 1 shows a schematic side view of a device according to a firstexemplary embodiment of the present disclosure, in a first position;

FIG. 2 shows a schematic side view of the device of FIG. 1, in a secondposition;

FIG. 3 shows a schematic side view of the device of FIG. 3, in a thirdposition.

FIG. 4 shows a schematic side view of a portion of the device of FIG. 1,in an anchoring configuration;

FIG. 5 shows a schematic side view of a portion of the device of FIG. 1,in an insertion configuration;

FIG. 6 shows a schematic side view of a portion of a device according toan alternate embodiment of the present disclosure, in an anchoringconfiguration;

FIG. 7 shows a schematic side view of a portion of the device of FIG. 4,in an insertion configuration;

FIG. 8 shows a schematic side view of a device according to a secondexemplary embodiment of the present disclosure, in a first position;

FIG. 9 shows a schematic side view of the device of FIG. 8, in a secondposition;

FIG. 10 shows a schematic side view of the device of FIG. 8, in a thirdposition;

FIG. 11 shows a schematic side view of a device according to a thirdexemplary embodiment of the present disclosure, in a first position;

FIG. 12 shows a schematic side view of the device of FIG. 11, in asecond position;

FIG. 13 shows a schematic side view of the device of FIG. 11, in a thirdposition;

FIG. 14 shows a longitudinal cross-sectional side view of a systemaccording to a further embodiment of the present disclosure;

FIG. 15 shows a cross-sectional side view of the system of FIG. 14, in afirst position;

FIG. 16 shows a cross-sectional side view of the system of FIG. 14, in asecond position;

FIG. 17 shows a cross-sectional side view of the system of FIG. 15, in athird position;

FIG. 18 shows a schematic side view of a device according to a fourthexemplary embodiment of the present disclosure;

FIG. 19 shows a schematic side view of an outer member of the device ofFIG. 18; and

FIG. 20 shows a schematic side view of an inner member of the device ofFIG. 18.

DETAILED DESCRIPTION

The present disclosure may be further understood with reference to thefollowing description and the appended drawings, wherein like elementsare referred to with the same reference numerals. The present disclosureis directed to devices for the treatment of tissue and, in particularendoscopic tissue treatment deices. Exemplary embodiments of the presentdisclosure describe an endoscopic staple including anchoring elementsfor anchoring the staple in a target tissue. The terms “proximal” and“distal” as used herein, refer to a direction extending toward(proximal) and away from (distal) a user of the device.

As shown in FIGS. 1-5, a staple device 100 for treating a tissue opening10 comprises a body 101 including a base portion 102 extending along afirst axis A from a first end 104 to a second end 106, a first leg 108extending from the first end 104 along a second axis B and a second leg110 extending from the second end 106 along a third axis C to beinserted into tissue on opposing sides of the tissue opening 10. Thefirst and second legs 108, 110 may extend from the base portion 102 suchthat the second and third axes B, C are angled with respect to the baseportion 102. In one embodiment, the second and third axes B, C may beperpendicular relative to the base portion 102 and parallel to oneanother. An angle between the first and second axes A, B and between thefirst and third axes A, C, however, may vary so long as the first andsecond legs 108, 110 extend in the same plane, along with the baseportion 102, toward the same side of the base portion 102. The first andsecond legs 108, 110 further include first and second anchoring elements112, 114, respectively, for anchoring the staple device 100 in thetissue into which it is inserted. The first and second anchoringelements 112, 114 are movable between an anchoring configuration, inwhich an engaging portion of each of the first and second anchoringelements 112, 114 extends laterally away from a corresponding one of thelegs 108, 110, and an insertion configuration, in which the engagingportion of each of the anchoring elements 108, 110 is moved toward thecorresponding one of the legs 108, 110.

The first leg 108 extends from the first end 104 of the base portion 102from a proximal end 116 connected to the first end 104 of the baseportion 102 to a distal end 118. The first leg 108 may be hollow,including an elongated slot 134 extending through a wall thereof along alength thereof, proximally from the second end 118 so that the elongatedslot 134 is open to an interior of the first leg 108. The first leg 108includes the first anchoring element 112, which includes a first portion120 and a second portion 122 pivotally connected to one another at apivot point 124. The first portion 120 extends from a first end 126connected to the distal end 118 of the first leg 108 to a second end128. The second portion 122 extends from a first end 130 connected tothe second end 128 of the first portion 120 via the pivot point 124 to asecond end 132. The second end 132 of the second portion 122 includes anenlarged end 136 received within the hollow first leg 108, across-sectional area of the enlarged end 136 being larger than a widthof the elongated slot 134 (e.g., a distance between longitudinallyextending edges of the elongated slot 134) so that the enlarged end 136is prevented from passing through the elongated slot 134 while thesecond portion 122 may be received therein allowing the enlarged end 136to slide along a length of the hollow first leg 108. As the enlarged end136 is slid along the hollow first leg 108, the first anchoring element112 is moved between the anchoring configuration and the insertionconfiguration.

In the anchoring configuration, as shown in FIG. 4, the enlarged end 136is received in the hollow first leg 108 proximate a proximal end of theelongated slot 134 so that the pivot point 124 extends away from thefirst leg 108 to engage tissue into which it is inserted. The pivotpoint 124 may be, for example, a living hinge biased toward theanchoring configuration. In one embodiment, the second portion 124extends substantially perpendicular to the first leg 108 in theanchoring configuration. In the insertion configuration, as shown inFIG. 5, the enlarged end 136 is slid distally through the first leg 108so that the enlarged end 136 is proximate a distal end of the elongatedslot 134. When the enlarged end 134 is slid toward the distal end 118 ofthe first leg 108, the first and second portions 120, 122 are pivotedrelative to one another such that the pivot point 124 is moved towardthe first leg 108. Thus, in the insertion configuration, the firstanchoring element 112, particularly the pivot point 124, is preventedfrom engaging tissue.

According to an alternate embodiment, as shown in FIGS. 6 and 7, a firstanchoring element 112′ of a first leg 108′ is formed by a portion 120′of an exterior wall cut and bent away therefrom so that the portion 120′is movable between an anchoring configuration and an insertionconfiguration. In particular, the portion 120′ extends from a distal end122′ which remains connected to the first leg 108′ to a proximal end124′ which extends away from the first leg 108′ in the anchoringconfiguration to engage a tissue into which it is inserted. The portion120′ may be, for example, heat set to be biased toward the anchoringconfiguration. In the insertion configuration, the proximal end 124′ ismoved toward the first leg 108′ to facilitate insertion thereof intotarget tissue. Although not shown, it will be understood by those ofskill in the art that an anchoring element of a second leg may besubstantially similar to the anchoring element 112′ of the first leg108′.

The second leg 110 extends from a proximal end 138 connected to thesecond end 106 of the base portion 102 to a distal end 140 including thesecond anchoring element 114. The second anchoring element 114 may, forexample, be substantially similar to the first anchoring element 112 ofthe first leg 108. In particular, the second anchoring element 114includes first and second portions 142, 144 pivotally connected to oneanother at a pivot point 146 which, when in a biased anchoringconfiguration, extends away from the second leg 110. When in aninsertion configuration, the pivot point 146 extends toward the secondleg 110. Similarly to the first anchoring element 112, the secondanchoring element 114 of the second leg 110 may be moved between theanchoring configuration and the insertion configuration via an enlargedend slidably received within a hollow portion of the second leg 110 viaan elongated slot.

According to an exemplary surgical method using the staple device 100,the staple device 100 is inserted to a target location within a body viaa working channel of an endoscope. The staple device 100 may bedelivered to the target via any known stapling device. As discussedabove, the first and second anchoring elements 112, 114 are biasedtoward the anchoring configuration so that, prior to insertion, as shownin FIG. 1, the pivot points 124, 146 thereof extend away from the firstand second legs 108, 110, respectively. As the staple device 100 isinserted into the target tissue as shown in FIG. 2, however, the firstportions 120, 138 of the first and second anchoring elements 112, 114,are moved toward the first and second legs 108, respectively, via aforce of the tissue into which the staple device 100 is inserted.Movement of the first portions 120, 142 toward the first and second legs108, 110 causes the pivot points 124, 146 to move toward the legs 108,110 so that the staple device 100 is moved from the anchoringconfiguration to the insertion configuration. Once the staple device 100has reached a desired position in the tissue, as shown in FIG. 3, thefirst and second anchoring elements 112, 114 are permitted to revert tothe biased anchoring configuration. The first and second anchoringelements 112, 114 are configured to facilitate ease of insertion of thefirst and second legs 108, 110 distally into tissue, while preventingthe staple device 100 from being moved proximally thereoutof.

In use, the first leg 108 may be inserted into a first portion of tissue12 on a first side of the tissue opening 10 while the second leg 110 isinserted into a second portion of tissue 14 on a second side of thetissue opening 10 opposing the first side. The base portion 102 acts asa bridge connecting the first and second portions of tissue 12, 14,effectively closing the tissue opening 10. The first and secondanchoring elements 112, 114 are anchored within the first and secondportions of tissue 12, 14 to hold the tissue opening 10 in a closedconfiguration.

As shown in FIGS. 8-10, a staple 200 according to a second exemplaryembodiment of the present disclosure is substantially similar to thestaple device 100 described above. Rather than legs extending at anangle relative to a base portion, however, the staple 200 is comprisedof a body 202 extending along a curve from a first end 204 to a secondend 206. The first end 204 includes a first anchoring element 212 andthe second end 206 includes a second element 214. The first and secondanchoring elements 212, 214 are substantially similar to the first andsecond anchoring elements 112, 114 described above in regard to thestaple device 100. The curved body 202 permits the staple device 200 tobe rotated into target tissue to close a tissue opening 20. Inparticular, as shown in FIG. 8, the first end 204 is first inserted intoa first portion 22 of tissue on a first side of the tissue opening 20and moved across the tissue opening 20 to extend through a secondportion of tissue 24 along a second side of the tissue opening 20substantially opposing the first side. As the first end 204 is insertedinto the tissue, the first anchoring element 212 is moved from a biasedanchoring configuration to an insertion configuration. The first end 204is passed through the second portion of tissue 24 until the first end204 extends proximally of a proximal surface thereof such that the firstanchoring element 212 is freed to revert to the biased anchoringconfiguration, as shown in FIG. 10. As shown in FIG. 10, the secondanchoring element 214 prevents the second end 206 of the staple device200 from being moved distally into the first portion of tissue 22 whilethe first anchoring element 212 prevents the first end 204 from beingmoved into the second portion of tissue 24 once it has been extendedproximally therebeyond. As the staple device 200 is rotated through thefirst and second portions of tissue 22, 24, the staple device 200bridges a gap between the first and second portions of tissue 22, 24,closing the tissue opening 20.

As shown in FIGS. 11-13, a staple device 300 according to a thirdexemplary embodiment of the present disclosure may be substantiallysimilar to the staple device 200 comprising a curved body 302 extendingfrom a first end 304 including a first anchoring element 312 to a secondend 306 including a second anchoring element 314. The first end 304 issharpened or tapered to facilitate piercing of a tissue into which it isinserted. The first anchoring element 312, however, may include aninflatable bulb which may be inflated via a user once the first end 304has been inserted distally through a first portion of tissue 32 along afirst side of a tissue opening 30, across the tissue opening 30 and intoa second portion of tissue 34 along a second side of the tissue opening30 substantially opposing the first side, to extend proximally from aproximal surface thereof. Once the first end 304 extends proximally ofthe proximal surface of the first portion of tissue 32, the inflatablebulb of the first anchoring element 312 is inflated, as shown in FIG.13. The second anchoring element 314 prevents the second end 306 of thebody 302 from being moved distally through the first portion of tissue.The second anchoring element 314 may be substantially similar to theanchoring elements described above in regard to the staples 100, 200. Inanother embodiment, the second anchoring element 314 may also include aninflatable bulb or a cap which may be coupled to the second end 306.

According to an embodiment in which both the first and second anchoringelements are inflatable bulbs, as shown in FIGS. 14-17, the body 302 maybe further comprised of an outer member 308 and an inner member 310slidably received within the outer member 308 and movable relative toone another between an insertion configuration and an anchoringconfiguration. The outer member 308 is biased to extend along a curvefrom a first end 316 to a second 318 and includes a lumen 313 extendingtherethrough from the first end 316 to the second end 318. The outermember 308 includes a groove extending along an interior surface of thelumen 313. In one embodiment, the groove extends circumferentially aboutthe interior surface of the lumen 313. The first anchoring element 312is connected to the first end 316 of the outer member 308. The innermember 310 is also biased to extend along a curve from a first end 338slidably received within the lumen 313 of the outer member 308 to asecond end 340 and includes a lumen 315 extending therethrough. Theinner member 310 also includes a stopper 311 configured as, for example,an o-ring extending about a proximal portion of the inner member 310.The stopper 311 may be configured to engage the groove extending alongthe interior surface of the lumen 313, when the staple device 300 is inthe anchoring configuration. The second anchoring element 314 isconnected to the second end 340 of the inner member 310.

The lumen 313 of the outer member 308 may be filled with a liquid forinflating the first and second anchoring elements 312, 314 uponinsertion of the staple device 300 to a desired position in targettissue. In particular, when the outer and inner members 308, 310 arecompressed (e.g., the inner member 310 is moved distally relative to theouter member 308) from the insertion configuration, in which the firstend 338 of the inner member 310 is received within a proximal portion ofthe outer member 308 proximate the second end 318, toward the anchoringconfiguration, in which the first end 338 is moved distally toward thefirst end 316 of the outer member 308, the inflating liquid is displacedinto the inflatable bulbs of the first and second anchoring elements312, 314, moving the first and second anchoring elements 312, 314 from adeflated configuration to an inflated configuration to anchor the stapledevice 300 in the target tissue.

The staple device 300 may be delivered to the target tissue via adelivery system 350 comprising a delivery catheter 352, a first plunger354 and a second plunger 356. The catheter 352 extends longitudinallyfrom a proximal end (not shown) to a distal end 358 and includes achannel 360 extending therethrough. The first plunger 354 is slidablyreceived within the channel 360, extending from a proximal end to adistal end 362 and including a plunger channel 364 extendingtherethrough. The first plunger 354 is sized and shaped such that whenthe first plunger 354 is moved distally relative to the catheter 352,the distal end 362 abuts the second end 318 of the outer member 308 topush the outer member 308 distally out of the catheter 352. The secondplunger 356 is slidably received within the plunger channel 364 of thefirst plunger 354, extending from a proximal end to a distal end 366.The second plunger 356 is sized and shaped such that, when the secondplunger 356 is moved distally relative to the catheter 352, the distalend 366 abuts the second end 340 of the inner member 310 to push theinner member 310 distally out of the delivery catheter 352.

The staple device 300 is loaded within the catheter 352 in the insertionconfiguration so that the outer member 308 is positioned distally of thefirst plunger 354 and the inner member 310 extends proximally from theouter member 308 and distally of the second plunger 356, as shown inFIG. 14. Although the outer and inner members 308, 310 are biased toextend along a curve, an interior surface of the channel 360 constrainsthe outer and inner members 308, 310 in a straightened position. Thecatheter 352, with the staple device 300 loaded therein, is inserted toa target location within a patient's body via, for example, a workingchannel of an endoscope. Once the catheter 352 has reached the targetlocation adjacent tissue to be treated, the first and second plungers354, 356 are moved distally relative to the catheter 352 to push thestaple device 300 out of the catheter 300, in the insertionconfiguration, as shown in FIG. 15. The first end 316 of the outermember 308 is inserted distally into the target tissue, the outer member308 reverting to its biased curved configuration as it extends distallyout of the catheter 352. The first and second plungers 354, 356 aremoved distally relative to the catheter 352 until the first end 316 ofthe outer member 308 curves through the target tissue to extendproximally past a proximal surface thereof.

Once the first end 316 is proximal of the proximal surface of thetissue, the staple device 300 is moved to the anchoring configuration bysliding the second plunger 356 distally relative to the first plunger354, as shown in FIG. 16, to move the inner member 310 distally into theouter member 308. Compression of the outer and inner members 308, 310causes the inflating fluid housed within the lumen 313 of the outermember 308 to become displaced, inflating the inflatable bulbs of thefirst and second anchoring elements 312, 314 via the lumens 313, 315,respectively, as shown in FIG. 17. The inner member 310 is moveddistally relative to the outer member 308 until the stop 311 along theproximal portion of the inner member 310 engages the groove along theinterior surface of the lumen 313 of the outer member 308, therebylocking the staple device 300 in the anchoring configuration in whichthe inflated bulbs of the first and second anchoring elements 312, 314anchor the staple device 300 in the target tissue.

As shown in FIGS. 18-20, a staple device 400 according to a fourthexemplary embodiment of the present disclosure is substantially similarto the staple device 300 comprising an outer member 408 and an innermember 410 slidably received therein. As shown in FIG. 19, the outermember 408 is biased to extend along a curve from a first end 416 to asecond end 418 and includes a lumen 413 extending therethrough. As shownin FIG. 20, the inner member 410 is also biased to extend along a curvefrom a first end 438 to a second end 440. The inner member 410 isslidably received within the lumen 413 of the outer member 408 andincludes a first anchoring element 412 at the first end 438 and a secondanchoring element 414 at the second end 440. The inner member 410 may beconfigured, for example, as a wire with the first and second anchoringelements 412, 414 being formed as portions of the wire bent and biasedlaterally away from a remaining length thereof.

The staple device 400 may be utilized in a manner substantially similarto the staple device 300. The staple device 400 is inserted to a targetlocation in a living body using, for example, the delivery system 350described above in regard to the staple device 300. In particular, thestaple device 400 may be loaded into the delivery catheter 352 so thatthe outer and inner members 408, 410 are constrained in a straightenedposition via an interior surface of the channel 360. The staple device400 is loaded in the catheter 352 in an insertion configuration in whichthe first end 438 of the inner member 410 does not extend distally fromthe first end 416 of the outer member 408. The staple device 400 isinserted into the target tissue in the insertion configuration, theouter member 408 reverting to its biased curved configuration as it ispushed distally out of the catheter 352 into the target tissue. Once thefirst end 416 of the outer member 408 extends proximally of a proximalsurface of the target tissue, the inner member 410 is moved distallyrelative to the outer member 408 until the first end 438 of the innermember 410 extends past the first end 438 of the outer member 408 sothat the first anchoring element 412 thereon reverts to its biased bentconfiguration. The second anchoring element 412 is also permitted torevert to its biased bent configuration as the inner member 410 ispushed entirely out of the catheter 352. Thus first and second anchoringelements 412, 414 extend out of the lumen 413 of the outer member 408,past the first and second ends 416, 418 thereof, respectively, to anchorthe staple device 400 in the target tissue.

It will be apparent to those skilled in the art that variousmodifications may be made in the present disclosure, without departingfrom the scope of the disclosure. Thus, it is intended that the presentdisclosure cover modifications and variations of this disclosureprovided that they come within the scope of the appended claims andtheir equivalents.

1-35. (canceled)
 36. A method for treating a tissue, comprising:inserting a staple device into a target tissue via a delivery catheterpassed through a working channel of an endoscope, the staple deviceincluding an outer member biased to extend along a curve from a distalend to a proximal end and an inner member slidably received within afirst lumen of the outer member and biased to extend along a curve froma distal end to a proximal end, the outer and inner members constrainedin a straight position via an interior surface of the delivery catheterin an insertion configuration, the distal end of the inner memberreceived within a proximal portion of the first lumen in the insertionconfiguration; moving the outer and inner members distally relative tothe delivery catheter so that the outer member is inserted into a targettissue until the distal end of the outer member extends proximally of aproximal surface of the target tissue, the outer member reverting to abiased curved configuration as the outer member is moved distally out ofthe delivery device; and moving the device from the insertionconfiguration to the anchoring configuration by moving the inner memberdistally relative to the outer member until a first anchoring element atthe proximal end of the inner member is moved distally out of thedelivery catheter.
 37. The method of claim 36, wherein the distal end ofthe outer member includes a second anchoring element.
 38. The method ofclaim 37, wherein each of the first and second anchoring elements areinflatable bulbs so that moving the device from the insertionconfiguration to the anchoring configuration includes moving the firstand second anchoring elements from a deflated configuration to aninflated configuration.
 39. The method of claim 38, wherein moving thedevice from the insertion configuration to the anchoring configurationcauses an inflating liquid housed within the first lumen to bedisplaced, filling the first and second anchoring elements via the firstlumen and a second lumen extending through the inner member.
 40. Themethod of claim 36, wherein the inner member is configured as a wireincluding a second anchoring element at the distal end thereof.
 41. Themethod of claim 40, wherein the first and second anchoring elements areformed via distal and proximal ends of the wire, respectively, biased tobend laterally away from a remaining portion thereof so that moving thedevice from the insertion configuration to the anchoring configurationincludes moving the first and second anchoring elements from thestraight position to the biased position.
 42. The method of claim 39,wherein, moving the device from the insertion configuration to theanchoring configuration includes moving the inner member distallyrelative to the outer member until the second anchoring member extendsdistally of the distal end of the outer member and the first anchoringelement extends proximally of the proximal end of the outer member. 43.The method of claim 36, wherein the outer member includes a grooveextending along an interior surface of the first lumen.
 44. The methodof claim 43, wherein the inner member includes a stopper configured aso-ring extending about a proximal portion of the inner member configuredto engage the groove when the staple device is in the anchoringconfiguration.
 45. A method for treating a tissue, comprising:delivering a staple device into a target tissue via a delivery systempassed through a working channel of an endoscope, the delivery systemincluding a delivery catheter, a first plunger and a second plunger, thestaple device including an outer member biased to extend along a curvefrom a distal end to a proximal end and an inner member slidablyreceived within a first lumen of the outer member and biased to extendalong a curve from a distal end to a proximal end, the outer and innermembers constrained in a straight position via an interior surface ofthe first lumen in an insertion configuration, the distal end of theinner member received within a proximal portion of the first lumen inthe insertion configuration; moving the outer and inner members distallyrelative to the delivery catheter, via the first and second plungers, sothat the outer member is inserted into a target tissue until the distalend of the outer member extends proximally of a proximal surface of thetarget tissue, the outer member reverting to a biased curvedconfiguration as the outer member is moved distally, via the firstplunger, out of the delivery device; and moving the device from theinsertion configuration to the anchoring configuration by moving theinner member distally, via the second plunger, relative to the outermember until a first anchoring element at the proximal end of the innermember is moved distally out of the delivery catheter.
 46. The method ofclaim 45, wherein the distal end of the outer member includes a secondanchoring element.
 47. The method of claim 46, wherein each of the firstand second anchoring elements are inflatable bulbs so that moving thedevice from the insertion configuration to the anchoring configurationincludes moving the first and second anchoring elements from a deflatedconfiguration to an inflated configuration.
 48. The method of claim 47,wherein moving the device from the insertion configuration to theanchoring configuration causes an inflating liquid housed within thefirst lumen to be displaced, filling the first and second anchoringelements via the first lumen and a second lumen extending through theinner member.
 49. The method of claim 45, wherein the first plunger isslidably received within a lumen of the catheter, the first plungerbeing sized and shaped such that when the first plunger is moveddistally relative to the catheter, a distal end thereof abuts theproximal end of the outer member to push the outer member distally outof the catheter.
 50. The method of claim 49, wherein the second plungeris slidably received in a plunger channel of the first plunger, thesecond plunger being sized and shaped such that, when the second plungeris moved distally relative to the catheter, a distal end of the secondplunger abuts a proximal end of the inner member to push the innermember distally out of the delivery catheter.
 51. The method of claim45, wherein the inner member is configured as a wire including a secondanchoring element at the distal end thereof.
 52. The method of claim 51,wherein the first and second anchoring elements are formed via distaland proximal ends of the wire, respectively, biased to bend laterallyaway from a remaining portion thereof so that moving the device from theinsertion configuration to the anchoring configuration includes movingthe first and second anchoring elements from the straight position tothe biased position.
 53. The method of claim 52, wherein, moving thedevice from the insertion configuration to the anchoring configurationincludes moving the inner member distally relative to the outer memberuntil the second anchoring member extends distally of the distal end ofthe outer member and the first anchoring element extends proximally ofthe proximal end of the outer member.
 54. The method of claim 45,wherein the outer member includes a groove extending along an interiorsurface of the first lumen.
 55. The method of claim 54, wherein theinner member includes a stopper configured as o-ring extending about aproximal portion of the inner member configured to engage the groovewhen the staple device is in the anchoring configuration.